A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Trail Making Test (TMT)
研究概览
简要总结
Cognitive complaints at menopause transition (MT), often described as 'brain fog'; can include difficulty recalling words and numbers, misplacing items, trouble concentrating and forgetfulness. Whilst these difficulties resolve for most people, several years of reduced cognitive functioning can be highly damaging and result in problems including leaving work, depression and relationship breakdown.
Study Aims: This project aims 1) to develop and finalise a cognitive intervention for the menopause, 2) To evaluate the feasibility, acceptability and preliminary effects of the intervention. 3) To evaluate the interventions preliminary effects on subjective and objective cognition
Relevance: Traditionally Menopause Hormone Therapy (MHT) is offered to women with cognitive complaints due to its beneficial effect. However, many women are unable to take it due to medical reasons or choose not to. If this intervention is concluded as feasible and acceptable it may then be appropriate to conduct a full RCT of this intervention. It could reduce excess disability, potentially enabling people to remain at work and function better in daily life. Costs to the NHS might be reduced through decreased service and medication use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •people with ovaries (women, trans-men and non-binary people) aged 40-60
- •late-reproductive, early-late perimenopause or early post-menopause stages according to the Stages of Reproductive Aging Workshop (STRAW+10; Harlow et al., 2012)
- •stable dose of hormonal (oestrogen, progesterone, testosterone) or antidepressant (SSRI, SSNI) medication for 6 months or more
- •self-reported cognitive difficulties impacting on quality of life
- •ability to communicate in English
排除标准
- •diagnosis of dementia
- •new regimen (under 6 months) of medication likely to impact on cognition (i.e. hormonal or anti-depressant)
研究组 & 干预措施
Treatment group
Treatment group participants will complete a 4 x 2-hour intervention. Key components will include education about menopause and cognition, cognitive strategies (memory, attention and executive functioning), CBT techniques and emotional support
干预措施: Online cognitive intervention (Other)
Control group
Treatment as usual
结局指标
主要结局
Trail Making Test (TMT)
时间窗: Pre-intervention and within 6 weeks post intervention
The TMT (Part A and B) is a neuropsychological test assessing executive function; shorter reaction times indicate better performance.
Digit Span subtest (WISC-V)
时间窗: Pre-intervention and within 6 weeks post intervention
The Digit Span test (backward and forward) is a neuropsychological test assessing attention and working memory.
Controlled Word Association Test
时间窗: Pre-intervention and within 6 weeks post intervention
The Controlled Word Association Test is a neuropsychological test assessing verbal fluency.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Pre-intervention and within 6 weeks post intervention
The PHQ9 is a self-administered questionnaire measuring levels of depression over the past 2 weeks. The questionnaire uses a 4-point Likert rating scale, ranging from 0 (not at all) to 3 (nearly every day). The total score can range from 0 to 27, with high scores meaning high depression.
Generalised Anxiety Disorder (GAD-7)
时间窗: Pre-intervention and within 6 weeks post intervention
The GAD 7 is a self-administered questionnaire measuring levels of anxiety over the past 2 weeks. The questionnaire uses a 4 Likert rating scale, ranging from 0 (not at all) to 3 (nearly every day). Total score can range from 0 to 21 and is categorised by 0-4 was no anxiety, 5-9 was mild anxiety, 10-14 was moderate anxiety, and 15 or above was severe anxiety.
Menopause-Specific Quality of Life (MENQoL)
时间窗: Pre-intervention and within 6 weeks post intervention
The MENQoL measures the quality of life over 4 domains of menopausal symptoms: Vasomotor, Psychosocial, Physical and Sexual, asking if a symptom is present or not and if it is to score how bothersome it is on a 7-point Likert scale, ranging from 0 'not bothered at all' to 6 'extremely bothered.
Hot Flush Rating Scale (HFRS)
时间窗: Pre-intervention and within 6 weeks post intervention
The HFRS is a self-report measure of the frequency and problem rating of hot flashes and night sweats (also known as vasomotor symptoms \[VMS\]) over the past week.
The Multifactoral Memory Questionnaire (MMQ)
时间窗: Pre-intervention and within 6 weeks post intervention
The MMQ measures self-reported cognitive functions with three subscales: abilities, contentment, strategies. Items are rated on a 5-point scale (0-4), lower scores indicate worse perceived memory.
Menopause-specific Cognitive Scale (MENO-Cog)
时间窗: Pre-intervention and within 6 weeks post intervention
The measure is in development with a PhD student in the same research team. It measures self-reported cognition functioning with a 5-point Likert scale; higher scores indicate worse perceived cognitive function.
Rey Auditory Verbal Learning Test (RAVLT)
时间窗: Pre-intervention and within 6 weeks post intervention
The RAVLT is a neuropsychological test measuring verbal learning and (immediate and delayed) verbal memory.
次要结局
- Post intervention interviews(Pre-intervention and within 6 weeks post intervention)